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Clinical Trials/NCT04210063
NCT04210063CompletedNot Applicable

Effect of Inspiratory Muscle Training (IMT) on Breathing, Balance, and Blood Pressure Maintenance in Spinal Cord Injury (SCI)

University of Miami2 sites in 1 country18 target enrollmentStarted: December 13, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
18
Locations
2
Primary Endpoint
Sustained Maximal Inspiratory Pressure (SMIP)

Study Overview

Brief Summary

The purpose of this study is to help understand how training breathing muscles will impact balance, blood pressure, and quality of life of participants with spinal cord injury.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Upper/lower/both extremity weakness or paralysis resulting from SCI with ASIA Impairment Scale (AIS) grades A-C who use a wheelchair as primary means of mobility.
  • ≥1 year post-injury
  • Willingness to participate in the study and provide consent.

Exclusion Criteria

  • Inability to understand the consent form or consent process
  • Reliance on a mechanical ventilator.
  • Use of Betablockers
  • Inability to travel to The Miami Project for weekly sessions during intervention month
  • Any complication that would limit transfer ability, or compromise supine or sitting tolerance, including but not limited to:
  • Fracture, dislocation, or malformations affecting supine or sitting tolerance.
  • Spinal instability.
  • Pressure ulcers or skin integrity issues on contact surfaces that would prohibit sitting or lying in supine.
  • Individuals who are able to stand independently or with a walker
  • Unresolved deep vein thrombosis (DVT).
  • Hospitalization due to autonomic dysreflexia in the last 3 months.
  • Pregnancy determined by urine testing in sexually active females.

Outcomes

Primary Outcomes

Sustained Maximal Inspiratory Pressure (SMIP)

Time Frame: Week 12

SMIP measured in pressure-time units (PTU) will be assessed using the Pro2 handheld inspiratory measurement and training device connected to a tablet, phone or desktop.

Root Mean Squared of Successive Differences between Normal Heartbeats (rMSSD)

Time Frame: Week 12

rMSSD, measured in milliseconds, will be derived from signals obtained by a Polar monitor (with elastic chest strap sensor) and analyzed using Kubios Heart Rate Variability (HRV) Analysis Software.

Functional Seated Balance

Time Frame: Week 12

Functional Seated Balance will be measured using the Function in Sitting Test for SCI (FIST-SCI). FIST-SCI consist of 14 different standardized seated balance tasks and scored on a 5-point ordinal scale from 0-4. A higher score indicates increased independence.

Quality of Life (QoL)

Time Frame: Week 12

QoL will be measured using the Quality of Life Index, SCI version (QOLI-SCI). QOLI-SCI is a set of two 37-items questionnaire with total scores ranging from 74 to 444 with the higher score indicating increased quality of life.

Independence

Time Frame: Week 12

Independence will be measured using the Spinal Cord Independence Measured (SCIM). SCIM has a total score ranging from 0-100 with the higher score indicating increased independence.

Percent Compliance of Training Sessions

Time Frame: 4 weeks

Feasibility of the IMT protocol will be reported as the percentage of completed daily sessions out of the 28 total session days.

Percent Compliance of Training Minutes

Time Frame: 4 weeks

Feasibility of the IMT protocol will also be reported as the percentage of completed total time out of the 840 minutes total expected session minutes(30 minutes daily for 28 days).

Maximal Inspiratory Pressure (MIP)

Time Frame: Week 12

MIP measured in cm H2O will be assessed using the Pro2 handheld inspiratory measurement and training device connected to a tablet, phone or desktop

Standard deviation of normal R-R intervals (SDNN)

Time Frame: Week 12

SDNN, measured in milliseconds, will be derived from signals obtained by a Polar monitor (with elastic chest strap sensor) and analyzed using Kubios Heart Rate Variability (HRV) Analysis Software.

Systolic Blood Pressure (SBP)

Time Frame: Week 12

Brachial systolic BP, evaluated in mmHg, will be evaluated using the contralateral arm with a Spot Vitals Monitor.

Secondary Outcomes

  • Maximal Expiratory Pressure (MEP)(Week 12)
  • Inspiratory Duration (ID)(Week 12)
  • Forced Vital Capacity(Week 12)
  • Forced Expiratory Volume in one Second (FEV1)(Week 12)
  • Peak Expiratory Flow (PEF)(Week 12)
  • Heart Rate Variability (HRV) Frequency(Week 12)
  • Diastolic Blood Pressure (DBP)(Week 12)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Lawrence Cahalin

Clinical Professor

University of Miami

Study Sites (2)

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